Efficacy and Safety of Oral Antiviral Therapy for Idiopathic Trigeminal Neuralgia (ANT-TN)

Efficacy and Safety of Oral Antiviral Drug Combined With Carbamazepine Versus Celecoxib Combined With Carbamazepine in the Treatment of Idiopathic Trigeminal Neuralgia: A Multicenter, Randomized Controlled Trial

This is a multicenter, prospective, randomized, controlled trial. A total of 165 patients with idiopathic trigeminal neuralgia will be enrolled and randomly divided into three groups at a 1:1:1 ratio. The aim is to compare the efficacy and safety of conventional carbamazepine monotherapy, carbamazepine combined with oral antiviral therapy, and carbamazepine combined with anti-inflammatory therapy in pain relief, quality of life improvement and adverse event profiles.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Trigeminal Neuralgia
• Intervention / Treatment: Drug: Intervention：Drug: Carbamazepine; Drug: Intervention：Drug: Carbamazepine + Acyclovir; Drug: Intervention：Drug: Carbamazepine + Celecoxib

Detailed Description

Idiopathic trigeminal neuralgia is a severe neuropathic pain disorder. Carbamazepine is the first-line conventional treatment, but some patients have insufficient pain relief or intolerable side effects. Viral latent infection and neuroinflammation are considered potential pathogenesis of trigeminal neuralgia. This study intends to explore whether adding oral antiviral agent (acyclovir) or non-steroidal anti-inflammatory drug (celecoxib) can further improve pain control, reduce carbamazepine consumption, improve mood status and quality of life, and ensure clinical safety. All participants will receive 12-week standardized treatment and follow-up at 1 week, 2 weeks, 1 month, 3 months and 6 months after enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianying Li tyli, doctor; Phone Number: +86-15560392365; Email: Litypacop@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with idiopathic trigeminal neuralgia according to standard clinical criteria.
2. No secondary etiology confirmed by cranial imaging.
3. No severe systemic disease or immune system disease.
4. Voluntary participation and signed informed consent.

Exclusion Criteria:

1. Secondary trigeminal neuralgia of any cause.
2. Active herpes zoster infection recently.
3. Severe hepatic or renal insufficiency or contraindications to study drugs.
4. Unable to complete questionnaire evaluation independently.
5. Pregnancy or lactation state. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm A：Control Group（Carbamazepine Monotherapy）; Intervention：Drug: Carbamazepine Dosage：Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.	Drug: Intervention：Drug: Carbamazepine; ArmA Dosage：Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.
Experimental: Arm B：Antiviral Combination Group（Carbamazepine + Acyclovir）; Intervention：Drug: Carbamazepine + Acyclovir Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.	Drug: Intervention：Drug: Carbamazepine + Acyclovir; ArmB Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
Experimental: Arm C：Anti-inflammatory Combination Group（Carbamazepine + Celecoxib）; Intervention：Drug: Carbamazepine + Celecoxib Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.	Drug: Intervention：Drug: Carbamazepine + Celecoxib; Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Visual Analogue Scale (VAS) Pain Score	Pain intensity is evaluated by VAS score. Effective pain relief is defined as a reduction of ≥50% from baseline VAS score.	Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life (SF-36) Score	1 week, 2 weeks, 1 month, 3 months
Anxiety and Depression Score (HADS)	1 week, 2 weeks, 1 month, 3 months
Average Daily Carbamazepine Consumption	1 week, 2 weeks, 1 month, 3 months
Adverse Event Incidence	Throughout 12-week treatment and follow-up period

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing Sanbo Brain Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Trigeminal Neuralgia; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Guanine; Hypoxanthines; Purinones; Purines; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Pyrazoles; Celecoxib; Acyclovir
• Other Study ID Numbers: KY2026-126-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly due to institutional data privacy regulations and patient confidentiality requirements. Data availability is limited to the research team and authorized institutional review personnel only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No